A trial looking at selumetinib and paclitaxel for a type of eye cancer called uveal melanoma (SelPac)

Cancer type:

Eye cancer

Melanoma

Status:

Open

Phase:

Phase 2

This trial is looking at selumetinib and paclitaxel for a type of eye cancer called uveal melanoma. It is for people whose uveal melanoma has spread elsewhere in the body. This trial is supported by Cancer Research UK.

Doctors usually treat uveal melanoma that has spread with chemotherapy or biological therapy or a combination of the two. Researchers are continually trying to find the best drugs to use.

Selumetinib is a type of biological therapy. It works by targeting a protein called MEK (so it is called a MEK inhibitor). MEK is a protein that sends signals to cells telling them to divide and grow.

Previous trials have shown that selumetinib may help to treat uveal melanoma that has spread. Very early research in the laboratory suggests that using selumetinib alongside a chemotherapy drug called paclitaxel may improve treatment.

The aim of the trial is to see if selumetinib and paclitaxel works better than selumetinib alone for uveal melanoma. The researchers will also try to find the best way to give these 2 drugs together.

Who can enter

The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.

You may be able to join this trial if all of the following apply. You

Have a type of cancer called uveal melanoma that has spread to another part of the body

Have cancer that can be measured using scans, or by the doctor examining you

Are willing to use reliable contraception during treatment if there is any chance that you or your partner could become pregnant

Are at least 18 years old

You cannot join this trial if any of these apply. You

Have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression) and this hasn’t been treated or is causing symptoms. You can take part if cancer spread to your brain has been treated with surgery or radiotherapy, has not got worse in the last 4 weeks and if you have not needed to take steroids or anti epileptic drugs in the last 4 weeks

Had any kind of cancer treatment in the last 3 weeks

Have already had chemotherapy for your uveal melanoma (including chemotherapy into the liver’s blood supply or chemoembolisation). You may be able to take part if you have any other local treatments to the liver (that have not included chemotherapy) and your cancer has continued to grow despite this treatment

Are still having side effects from any anti cancer treatment, apart from hair loss

Have already had treatment with drugs that block the action of certain proteins called MEK, Ras or Raf

Have a medical condition or have had treatment that means your body cannot absorb tablets so well. For example, conditions such as coeliac disease or past surgery to remove part of your bowel of stomach

Have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Trial design

It is a randomised trial. The people taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone has selumetinib. People in the other 2 groups also have paclitaxel.

One group has selumetinib on its own

Another group has selumetinib and paclitaxel

The other group has selumetinib and paclitaxel except for 2 days before each treatment with paclitaxel

If you are in the 1st group, you have 3 selumetinib capsules twice a day, every day, at least 12 hours apart. You take the capsules with 240 mls of water. You need to have these on an empty stomach, no food and drink (other than water) for 2 hours before and 2 hours after.

If you are in 2nd group, you have selumetinib capsules in the same way as the 1st group. You go to hospital to have paclitaxel through a drip into a vein (an infusion), this takes about 1 hour. You have this once every week for 3 weeks, then no paclitaxel in the 4th week. Each 4 week period is called a cycle of treatment.

If you are in the 3rd group, you have selumetinib and paclitaxel in the same way as the 2nd group. Except that you do not take any selumetinib for 2 days before each paclitaxel treatment. You then start taking your capsules again on the day of your chemotherapy treatment.

If you are having paclitaxel, you have up to 6 cycles. Then you continue taking selumetinib twice a day, every day.

You continue selumetinib treatment for as long as it is helping you and you don’t have any serious side effects.

The researchers will ask for your permission to look at a sample of your cancer removed when you had surgery or a biopsy. They may also ask if they can carry out a biopsy of your cancer at the end of your treatment. They want to look for biomarkers to find out why treatment might work for some people and not for others.

You are asked to provide extra blood samples as part of this trial at various points throughout the trial. Where possible you have these at the same time as your routine blood tests. These samples will be used to help the researchers learn more about uveal melanoma.

You don’t have to agree to these extra blood and cancer samples if you don’t want to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

You may also have an MRI scan. Everyone has further have blood tests before each cycle of treatment (every 4 weeks). If you are having paclitaxel, you also have blood tests in the 2nd and 3rd week of each cycle (before each paclitaxel infusion).

If you develop any problems with your vision, you have regular eye examinations during and after treatment if necessary.

If you stop treatment in this trial, you have a final appointment with a doctor in the trial team. They will examine you and ask about any side effects. Your care will then continue with your own doctor who can discuss other treatment options and support with you.

If you stop treatment in this trial and your cancer has stayed the same and not started to grow (stable disease), you may have a CT scan every 2 months.

Side effects

As selumetinib is a new drug, there may be side effects we don’t know about yet. If you have any of the following you should contact your medical team or study doctor immediately as you may need treatment

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